Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06166082
NA

Intensive Accelerated iTBS for the Treatment-Resistant Depression

Sponsor: Changping Laboratory

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized, double-blind, and sham-controlled trial using most intensive aiTBS protocol (10 sessions daily over 5 consecutive days at triple the standard per-session dose) to investigate the antidepressant efficacy for treatment-resistant depression (TRD). Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.

Official title: Intensive Accelerated Intermittent Theta Burst Stimulation in Treatment-resistant Depression: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial

Key Details

Gender

All

Age Range

22 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2023-12-22

Completion Date

2025-04-21

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DEVICE

Active iTBS-DLPFC

Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.

DEVICE

Sham iTBS-DLPFC

The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.

Locations (5)

Hebei Mental Health Center

Baoding, China

HuiLongGuan Hospital

Beijing, China

Wuhan Mental Health Center

Wuhan, China

Xianyue Hospital

Xiamen, China

Zhumadian Second People's Hospital

Zhumadian, China